Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000265-37 | EudraCT Number |
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Study Was Terminated Early
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BGB-A333 is a humanized IgG1-variant monoclonal antibody against programmed cell death 1-ligand 1 (PD-L1), the ligand of an immune check point- receptor, programmed cell death-1 (PD-1). BGB-A317 is a humanized, IgG4-variant monoclonal antibody against PD-1. This study tested the safety and anti-tumor effect of BGB-A333 alone and in combination with BGB-A317 in participants with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1A: BGB-A333 monotherapy dose escalation | Experimental |
| |
| Phase 2A: BGB-A333 monotherapy dose expansion | Experimental |
| |
| Phase 1B: BGB-A333 and BGB-A317 dose confirmation | Experimental |
| |
| Phase 2B: BGB-A333 and BGB-A317 dose expansion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGB-A333 | Drug | Anti-PD-L1 antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 and Phase 2 : Number of Participants With Adverse Events and Serious Adverse Events | Adverse events were assessed per the National Cancer Institute Common Terminology Criteria for Adverse Events NCI-CTCAE Version 4.03 Serious Adverse Events (SAEs) were monitored from the date of informed consent. All adverse events (AEs) and SAEs, were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first. | Up to 33.5 months |
| Phase 1 and Phase 2 : Number of Participants With Abnormalities During Physical Examinations - Ophthalmology Findings | Complete physical examination including an evaluation of 1) head, eyes, ears, nose, throat, 2) cardiovascular, 3) dermatological, 4) musculoskeletal, 5) respiratory, 6) gastrointestinal, and 7) neurological systems was required to be performed at Screening. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations were performed. Clinically significant Ophthalmology abnormalities were collected from case report forms. All AEs and SAEs, were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first. | Up to 33.5 months |
| Phase 1 and Phase 2 : Number of Participants With Abnormal Electrocardiograms (ECG) | Central ECG data was used and the abnormality was determined by the evaluator (Investigating physician). Multiple tests such as QT, HR, PR, RR were used by the evaluator to determine abnormality. All AEs and SAEs, were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first. | Up to 33.5 months |
| Phase 1 and Phase 2 : Number of Participants With Abnormal Lab Assessment Results | Lab abnormality was based on ANRIND: if the measurement value > upper limit of normal (ULN), it was considered Abnormal. All AEs and SAEs, were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1A and Phase 1B: Overall Response Rate (ORR) Determined by Investigators Based on RECIST Version 1.1 | ORR is defined as the percentage of participants who had confirmed CR or PR assessed by investigator using RECIST version 1.1. | Up to 33.5 months |
| Phase 2B: Duration of Response (DOR) Determined by Investigators Based on RECIST Version 1.1 |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monash Health | Clayton | Victoria | 3168 | Australia | ||
| Peter Maccallum Cancer Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36797356 | Derived | Desai J, Fong P, Moreno V, Frentzas S, Meniawy T, Markman B, Voskoboynik M, Rahman T, Budha N, Wu J, Marlow J, Yang S, Calvo E, Martin-Liberal J. A Phase 1/2 study of the PD-L1 inhibitor, BGB-A333, alone and in combination with the PD-1 inhibitor, tislelizumab, in patients with advanced solid tumours. Br J Cancer. 2023 Apr;128(8):1418-1428. doi: 10.1038/s41416-022-02128-3. Epub 2023 Feb 16. |
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This study was conducted at 8 study centers in Australia, 1 study center in New Zealand, and 3 study centers in Spain. A total of 39 patients were enrolled in the study and all received ≥ 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1A: BGB-A333 450 mg | BGB-A333 450 mg, intravenously, every 3 weeks |
| FG001 | Phase 1A: BGB-A333 900mg | BGB-A333 900mg, intravenously, every 3 weeks |
| FG002 | Phase 1A: BGB-A333 1350 mg | BGB-A333 1350 mg, intravenously, every 3 weeks |
| FG003 | Phase 1A: BGB-A333 1800 mg | BGB-A333 1800 mg, intravenously, every 3 weeks |
| FG004 | Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg | BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks |
| FG005 | Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg | BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1A: BGB-A333 450 mg | BGB-A333 450 mg, intravenously, every 3 weeks |
| BG001 | Phase 1A: BGB-A333 900mg | BGB-A333 900mg, intravenously, every 3 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase 1 and Phase 2 : Number of Participants With Adverse Events and Serious Adverse Events | Adverse events were assessed per the National Cancer Institute Common Terminology Criteria for Adverse Events NCI-CTCAE Version 4.03 Serious Adverse Events (SAEs) were monitored from the date of informed consent. All adverse events (AEs) and SAEs, were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first. | Safety Analysis Set included all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Up to 33.5 months |
|
From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1A: BGB-A333 450 mg | BGB-333 450 mg, intravenously, every 3 weeks | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
Phase 2A of the study was not initiated nor conducted since BGB-A333 as a monotherapy treatment beyond the completion of dose escalation in Phase 1A was not pursued.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | BeiGene | +1-877-828-5568 | clinicaltrials@beigene.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 12, 2018 | Sep 3, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 12, 2020 | Sep 3, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C000707970 | tislelizumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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| BGB-A317 | Drug | Anti-PD-1 antibodies |
|
|
| Up to 33.5 months |
| Phase 1 A: Recommended Phase 2 Dose (RP2D) for BGB-333 | RP2D for BGB-A333 alone and in combination with tislelizumab was the maximum tolerated dose (MTD) or less, which was determined by testing increasing doses up to 1800 mg. | Up to 28 months |
| Phase 2B: Overall Response Rate (ORR) Determined by Investigators Based on RECIST Version 1.1 | The ORR is defined as the percentage of participants who had confirmed Complete Response (CR) or Partial response (PR) assessed by investigator using RECIST version 1.1 | Up to 33.5 months |
DOR was defined as the time from the first determination of an objective response per RECIST version 1.1, until the first documentation of progression or death, whichever occurs first. DOR was not evaluable in Phase 1A and Phase 1B. |
| Up to 33.5 months |
| Phase 1 and Phase 2: Disease Control Rate (DCR) Determined by Investigators Based on RECIST Version 1.1 | DCR is defined as the percentage of participants with best overall response of CR, PR and Stable Disease. | Up to 33.5 months |
| Phase 2B: Progression-free Survival (PFS) Determined by Investigators Based on RECIST Version 1.1 | PFS was defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of disease progression assessed by investigator using RECIST v1.1 or death, whichever occurs first | Up to 33.5 months |
| Phase 1: Maximum Plasma Concentration (Cmax) of BGB-A333 | PK parameters were derived only for Phase 1A and Phase 1B. Phase 2B pharmacokinetic (PK) parameters were not estimated due to limited sampling. | Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21 |
| Phase 1: Time to Cmax (Tmax) of BGB-A333 | PK parameters were derived only for Phase 1A and Phase 1B. Phase 2B PK parameters were not estimated due to limited sampling. | Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21 |
| Phase 1:Trough Serum Concentration (Ctrough) of BGB-A333 | PK parameters were derived only for Phase 1A and Phase 1B. Phase 2B PK parameters were not estimated due to limited sampling. | Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21 |
| Phase 1: Time to Last Observed Concentration (Tlast) of BGB-A333 | PK parameters were derived only for Phase 1A and Phase 1B. Phase 2B PK parameters were not estimated due to limited sampling. Actual observed time values for PK sampling, have an allowable time deviation (+/- 3 days) from the planned nominal time as pre-specified in the Visit Window section of the study protocol. | Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21 |
| Phase 1: Area Under the Concentration-time Curve From 0 to 21 Days Post-dose (AUC 0-21day) of BGB-A333 | PK parameters were derived only for Phase 1A and Phase 1B. Phase 2B PK parameters were not estimated due to limited sampling. | Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21 |
| Phase 1A and Phase 2: Number of Participants With Detectable Treatment-Emergent Anti-BGB-A333 Antibodies | Treatment-emergent anti drug antibodies (ADA) was the sum of both treatment-induced ADA and treatment-boosted ADA, synonymous with "ADA Incidence." | Up to 33.5 months |
| Melbourne |
| Victoria |
| 3000 |
| Australia |
| Nucleus Network | Melbourne | Victoria | 3004 | Australia |
| Linear Clinical Research | Nedlands | Western Australia | 6009 | Australia |
| Auckland City Hospital | Auckland | 1023 | New Zealand |
| Institut Catala Doncologia | Barcelona | 08908 | Spain |
| Start Madrid Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Centro Integral Oncologico Clara Campal | Madrid | 28050 | Spain |
| Death |
|
| Withdrawal by Subject |
|
| Study terminated by sponsor |
|
| Disease progression |
|
| Lost to Follow-up |
|
| Deteriorating condition |
|
| BG002 | Phase 1A: BGB-A333 1350 mg | BGB-A333 1350 mg, intravenously, every 3 weeks |
| BG003 | Phase 1A: BGB-A333 1800 mg | BGB-A333 1800 mg, intravenously, every 3 weeks |
| BG004 | Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg | BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks |
| BG005 | Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg | BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Programmed death-ligand 1 (PD-L1) Status | Number | participants |
|
BGB-A333 900mg, intravenously, every 3 weeks |
| OG002 | Phase 1A: BGB-A333 1350 mg | BGB-A333 1350 mg, intravenously, every 3 weeks |
| OG003 | Phase 1A: BGB-A333 1800 mg | BGB-A333 1800 mg, intravenously, every 3 weeks |
| OG004 | Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg | BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks |
| OG005 | Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg | BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks |
|
|
| Primary | Phase 1 and Phase 2 : Number of Participants With Abnormalities During Physical Examinations - Ophthalmology Findings | Complete physical examination including an evaluation of 1) head, eyes, ears, nose, throat, 2) cardiovascular, 3) dermatological, 4) musculoskeletal, 5) respiratory, 6) gastrointestinal, and 7) neurological systems was required to be performed at Screening. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations were performed. Clinically significant Ophthalmology abnormalities were collected from case report forms. All AEs and SAEs, were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first. | Safety Analysis Set included all participants who received at least 1 dose of study drug. | Posted | Number | participants | Up to 33.5 months |
|
|
|
| Primary | Phase 1 and Phase 2 : Number of Participants With Abnormal Electrocardiograms (ECG) | Central ECG data was used and the abnormality was determined by the evaluator (Investigating physician). Multiple tests such as QT, HR, PR, RR were used by the evaluator to determine abnormality. All AEs and SAEs, were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first. | Safety Analysis Set included all participants who received at least 1 dose of study drug. | Posted | Number | participants | Up to 33.5 months |
|
|
|
| Primary | Phase 1 and Phase 2 : Number of Participants With Abnormal Lab Assessment Results | Lab abnormality was based on ANRIND: if the measurement value > upper limit of normal (ULN), it was considered Abnormal. All AEs and SAEs, were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first. | Safety Analysis Set included all participants who received at least 1 dose of study drug. | Posted | Number | participants | Up to 33.5 months |
|
|
|
| Primary | Phase 1 A: Recommended Phase 2 Dose (RP2D) for BGB-333 | RP2D for BGB-A333 alone and in combination with tislelizumab was the maximum tolerated dose (MTD) or less, which was determined by testing increasing doses up to 1800 mg. | Safety Analysis Set included all participants who received at least 1 dose of study drug | Posted | Number | mg | Up to 28 months |
|
|
|
| Primary | Phase 2B: Overall Response Rate (ORR) Determined by Investigators Based on RECIST Version 1.1 | The ORR is defined as the percentage of participants who had confirmed Complete Response (CR) or Partial response (PR) assessed by investigator using RECIST version 1.1 | Safety Analysis Set (also used for efficacy analysis) included all participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 33.5 months |
|
|
|
| Secondary | Phase 1A and Phase 1B: Overall Response Rate (ORR) Determined by Investigators Based on RECIST Version 1.1 | ORR is defined as the percentage of participants who had confirmed CR or PR assessed by investigator using RECIST version 1.1. | Safety Analysis Set included (also used for efficacy analysis) all participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 33.5 months |
|
|
|
| Secondary | Phase 2B: Duration of Response (DOR) Determined by Investigators Based on RECIST Version 1.1 | DOR was defined as the time from the first determination of an objective response per RECIST version 1.1, until the first documentation of progression or death, whichever occurs first. DOR was not evaluable in Phase 1A and Phase 1B. | Safety Analysis Set (also used for efficacy analysis) included all participants who received at least 1 dose of study drug. | Posted | Median | 95% Confidence Interval | Months | Up to 33.5 months |
|
|
|
| Secondary | Phase 1 and Phase 2: Disease Control Rate (DCR) Determined by Investigators Based on RECIST Version 1.1 | DCR is defined as the percentage of participants with best overall response of CR, PR and Stable Disease. | Safety Analysis Set included all participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 33.5 months |
|
|
|
| Secondary | Phase 2B: Progression-free Survival (PFS) Determined by Investigators Based on RECIST Version 1.1 | PFS was defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of disease progression assessed by investigator using RECIST v1.1 or death, whichever occurs first | Safety Analysis Set included all participants who received at least 1 dose of study drug. | Posted | Median | 95% Confidence Interval | Months | Up to 33.5 months |
|
|
|
| Secondary | Phase 1: Maximum Plasma Concentration (Cmax) of BGB-A333 | PK parameters were derived only for Phase 1A and Phase 1B. Phase 2B pharmacokinetic (PK) parameters were not estimated due to limited sampling. | The PK analysis population includes all participants with valid PK sampling after treatment with study drug(s) | Posted | Mean | Standard Deviation | μg/mL | Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21 |
|
|
|
| Secondary | Phase 1: Time to Cmax (Tmax) of BGB-A333 | PK parameters were derived only for Phase 1A and Phase 1B. Phase 2B PK parameters were not estimated due to limited sampling. | The PK analysis population includes all participants with valid PK sampling after treatment with study drug(s) | Posted | Median | Full Range | Day | Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21 |
|
|
|
| Secondary | Phase 1:Trough Serum Concentration (Ctrough) of BGB-A333 | PK parameters were derived only for Phase 1A and Phase 1B. Phase 2B PK parameters were not estimated due to limited sampling. | The PK analysis population includes all participants with valid PK sampling after treatment with study drug(s) | Posted | Mean | Standard Deviation | μg/mL | Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21 |
|
|
|
| Secondary | Phase 1: Time to Last Observed Concentration (Tlast) of BGB-A333 | PK parameters were derived only for Phase 1A and Phase 1B. Phase 2B PK parameters were not estimated due to limited sampling. Actual observed time values for PK sampling, have an allowable time deviation (+/- 3 days) from the planned nominal time as pre-specified in the Visit Window section of the study protocol. | The PK analysis population includes all participants with valid PK sampling after treatment with study drug(s) | Posted | Median | Full Range | Day | Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21 |
|
|
|
| Secondary | Phase 1: Area Under the Concentration-time Curve From 0 to 21 Days Post-dose (AUC 0-21day) of BGB-A333 | PK parameters were derived only for Phase 1A and Phase 1B. Phase 2B PK parameters were not estimated due to limited sampling. | The PK analysis population includes all participants with valid PK sampling after treatment with study drug(s) | Posted | Mean | Standard Deviation | μg*day/mL | Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21 |
|
|
|
| Secondary | Phase 1A and Phase 2: Number of Participants With Detectable Treatment-Emergent Anti-BGB-A333 Antibodies | Treatment-emergent anti drug antibodies (ADA) was the sum of both treatment-induced ADA and treatment-boosted ADA, synonymous with "ADA Incidence." | ADA analysis set included participants who received ≥ 1 dose of study drug(s), BGB-A333 in Phase 1A or BGB-A333 and tislelizumab in Phase 1B and Phase 2B and had ≥ 1 evaluable ADA result after treatment. | Posted | Number | participants | Up to 33.5 months |
|
|
|
| 3 |
| 0 |
| 3 |
| 1 |
| 3 |
| EG001 | Phase 1A: BGB-A333 900 mg | BGB-333 900 mg, intravenously, every 3 weeks | 1 | 3 | 1 | 3 | 2 | 3 |
| EG002 | Phase 1A: BGB-333 1350 mg | BGB-333 1350 mg, intravenously, every 3 weeks | 2 | 6 | 3 | 6 | 6 | 6 |
| EG003 | Phase 1A: BGB-333 1800 mg | BGB-333 1800 mg, intravenously, every 3 weeks | 1 | 3 | 1 | 3 | 3 | 3 |
| EG004 | Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg | BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks | 4 | 12 | 5 | 12 | 12 | 12 |
| EG005 | Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg | BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks | 2 | 12 | 3 | 12 | 12 | 12 |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
|
| Vestibular neuronitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
|
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
|
| Hypophysitis | Endocrine disorders | MedDRA (23.0) | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA (23.0) | Systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA (23.0) | Systematic Assessment |
|
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA (23.0) | Systematic Assessment |
|
| Parainfluenzae virus infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (23.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (23.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (23.0) | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (23.0) | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (23.0) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA (23.0) | Systematic Assessment |
|
| Perineal pain | Reproductive system and breast disorders | MedDRA (23.0) | Systematic Assessment |
|
BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information & may request a further delay to protect its IP rights